> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/empagliflozin-09301932-ac0f-4eb7-8d1d-bd13fdbb6ab8 > Record changed: 2026-10-13 # Empagliflozin Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107830) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107830) First approval year 2014 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107830) ## Development status **First approval year** 2014 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107830) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107830) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107830) **Drug name** Empagliflozin Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107830) **Molecular weight** 450.92 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107830) **Structure (SMILES)** OC\[C@H\]1O\[C@@H\](c2ccc(Cl)c(Cc3ccc(O\[C@H\]4CCOC4)cc3)c2)\[C@H\](O)\[C@@H\](O)\[C@@H\]1O Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107830) ### Brand names (10) - bi 10773 - Bi 10773 - empagliflozin component of glyxambi - Empagliflozin component of glyxambi - empagliflozin component of synjardy - Empagliflozin component of synjardy - empagliflozin component of trijardy xr - Empagliflozin component of trijardy xr - jardiance - Jardiance ### Other names (81) - 12 5 mg empagliflozin - 12.5 mg empagliflozin - 5 mg empagliflozin - bi 10773 - BI 10773 - BI 10773 (Final Formulation) - BI 10773 (high) - BI 10773 (low) - BI 10773 25 mg - BI-10773 - bi10773 - Bi10773 - BI10773 - d glucitol 1 5 anhydro 1 c 4 chloro 3 4 3s tetrahydro 3 furanyl oxy phenyl methyl phenyl 1s - D-Glucitol, 1,5-anhydro-1-C-\[4-chloro-3-\[\[4-\[\[(3S)-tetrahydro-3-furanyl\]oxy\]phenyl\]methyl\]phenyl\]-, (1S)- - empagliflozin - Empagliflozin - EMPAGLIFLOZIN - Empagliflozin (BI 10773) - Empagliflozin (EMPA) - empagliflozin (high dose bid) - Empagliflozin (high dose qd) - empagliflozin (Jardiance) 25 mg - empagliflozin (low dose bid) - empagliflozin (low dose qd) And 56 more, listed on the interactive page. ## Identifiers **ATC classification codes** - A10BK03 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107830) **CAS registry numbers** - 864070-44-0 **ChEMBL ID** CHEMBL2107830 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107830) **InChIKey** OBWASQILIWPZMG-QZMOQZSNSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2107830) **PubChem compound IDs** - 11949646 **RxNorm IDs (RxCUI)** - 1545653 **FDA ingredient codes (UNII)** - HDC1R2M35U ## Regulatory information ### United States **Applicant** BOEHRINGER INGELHEIM **Approval date** 1 Aug 2014 **Application number** NDA204629 ### European Union **Status** Authorised **Status date** 22 May 2014 **Authorisation date** 22 May 2014 **Approved indications** Type 2 diabetes mellitus Jardiance is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance in addition to other medicinal products for the treatment of diabetes For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1\. Heart failure Jardiance is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease Jardiance is indicated in adults for the treatment of chronic kidney disease. **Product number** EMEA/H/C/002677 **Authorisation holder** Boehringer Ingelheim International GmbH **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Diabetes Mellitus, Type 2 - Heart Failure - Renal Insufficiency, Chronic European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/jardiance) ### Other regulatory facts **Patents** 27 **Designations** 2 **Earliest recorded loss of exclusivity** 11 Dec 2034 **First in class** No **Fast track** No **Breakthrough designation** Yes **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** empagliflozin **Type** Synthetic organic **Drug name stem** \-gliflozin **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral ### Mechanisms of action (3) - **Action** Inhibition **Action type** Inhibitor **Target** Sodium/glucose cotransporter 1 **Gene symbol** SLC5A1 **Protein identifier** P13866 **Median affinity** 5.1 **Affinity units** pIC50 - **Action** Inhibition **Action type** Inhibitor **Target** Sodium/glucose cotransporter 2 **Gene symbol** SLC5A2 **Protein identifier** P31639 **Median affinity** 8.5 **Affinity units** pIC50 **Primary target** Yes - **Mechanism** Sodium/glucose cotransporter 2 inhibitor **Action type** Inhibitor **Target** Sodium/glucose cotransporter 2 **Protein identifier** P31639 ### Open Targets mechanisms - **Mechanism** Sodium/glucose cotransporter 2 inhibitor **Action type** Inhibitor **Target** Sodium/glucose cotransporter 2 ### DrugCentral mechanisms - **Action type** Inhibitor **Gene symbol** SLC5A2 **Protein identifier** P31639 **Organism** Homo sapiens **Target development level** Clinical ### Investigated indications (37) - **Condition** Metabolic Syndrome **Highest recorded phase** 3 **Condition identifier** EFO:0000195 **Subject identifier** D024821 - **Condition** Crohn Disease **Highest recorded phase** 1 **Condition identifier** EFO:0000384 **Subject identifier** D003424 - **Condition** Diabetes Mellitus **Highest recorded phase** 4 **Condition identifier** EFO:0000400 **Subject identifier** D003920 - **Condition** Diabetic Nephropathies **Highest recorded phase** 3 **Condition identifier** EFO:0000401 **Subject identifier** D003928 - **Condition** Epilepsy **Highest recorded phase** 0.5 **Condition identifier** EFO:0000474 **Subject identifier** D004827 - **Condition** Myocardial Infarction **Highest recorded phase** 3 **Condition identifier** EFO:0000612 **Subject identifier** D009203 - **Condition** Polycystic Ovary Syndrome **Highest recorded phase** 2 **Condition identifier** EFO:0000660 **Subject identifier** D011085 - **Condition** Hypertension, Portal **Highest recorded phase** 2 **Condition identifier** EFO:0000666 **Subject identifier** D006975 - **Condition** Severe Acute Respiratory Syndrome **Highest recorded phase** 3 **Condition identifier** EFO:0000694 **Subject identifier** D045169 - **Condition** Colitis, Ulcerative **Highest recorded phase** 2 **Condition identifier** EFO:0000729 **Subject identifier** D003093 - **Condition** Insulin Resistance **Highest recorded phase** 3 **Condition identifier** EFO:0002614 **Subject identifier** D007333 - **Condition** Kidney Diseases **Highest recorded phase** 2 **Condition identifier** EFO:0003086 **Subject identifier** D007674 - **Condition** Non-alcoholic Fatty Liver Disease **Highest recorded phase** 3 **Condition identifier** EFO:0003095 **Subject identifier** D065626 - **Condition** Heart Failure **Highest recorded phase** 4 **Condition identifier** EFO:0003144 **Subject identifier** D006333 - **Condition** Inflammatory Bowel Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0003767 **Subject identifier** D015212 - **Condition** Renal Insufficiency, Chronic **Highest recorded phase** 4 **Condition identifier** EFO:0003884 **Subject identifier** D051436 - **Condition** Kidney Calculi **Highest recorded phase** 2 **Condition identifier** EFO:0004253 **Subject identifier** D007669 - **Condition** Diabetes, Gestational **Highest recorded phase** 3 **Condition identifier** EFO:0004593 **Subject identifier** D016640 - **Condition** Myocardial Infarction **Highest recorded phase** 3 **Condition identifier** EFO:0008583 **Subject identifier** D009203 - **Condition** ST Elevation Myocardial Infarction **Highest recorded phase** 2 **Condition identifier** EFO:0008585 **Subject identifier** D000072657 - **Condition** Kidney Failure, Chronic **Highest recorded phase** 2 **Condition identifier** EFO:0009909 **Subject identifier** D007676 - **Condition** Diabetic Neuropathies **Highest recorded phase** 1 **Condition identifier** EFO:1000783 **Subject identifier** D003929 - **Condition** Inappropriate ADH Syndrome **Highest recorded phase** 2 **Condition identifier** EFO:1000982 **Subject identifier** D007177 - **Condition** Prediabetic State **Highest recorded phase** 2 **Condition identifier** EFO:1001121 **Subject identifier** D011236 - **Condition** Cardiotoxicity **Highest recorded phase** 3 **Condition identifier** EFO:1001482 **Subject identifier** D066126 And 12 more, listed on the interactive page. ### Open Targets indications (122) - **Condition identifier** EFO\_0000195 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000266 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000319 - **Condition identifier** EFO\_0000373 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000400 - **Condition identifier** EFO\_0000401 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000474 - **Condition identifier** EFO\_0000537 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000612 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000729 **Highest recorded phase** 2 - **Condition identifier** EFO\_0001361 **Highest recorded phase** 2 - **Condition identifier** EFO\_0002503 **Highest recorded phase** 2 - **Condition identifier** EFO\_0002546 **Highest recorded phase** 2 - **Condition identifier** EFO\_0002687 - **Condition identifier** EFO\_0003086 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003095 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003144 - **Condition identifier** EFO\_0003884 - **Condition identifier** EFO\_0003913 **Highest recorded phase** 1 - **Condition identifier** EFO\_0004253 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004517 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004593 **Highest recorded phase** 3 - **Condition identifier** EFO\_0005207 **Highest recorded phase** 3 - **Condition identifier** EFO\_0008583 **Highest recorded phase** 3 - **Condition identifier** EFO\_0008585 **Highest recorded phase** 2 And 97 more, listed on the interactive page. ### Reported adverse events (24) - **Event** acute kidney injury **Reports** 553 **Reporting signal score** 263.532 - **Event** arthralgia **Reports** 50 **Reporting signal score** 192.838 - **Event** blood ketone body increased **Reports** 120 **Reporting signal score** 466.095 - **Event** dehydration **Reports** 530 **Reporting signal score** 312.821 - **Event** diabetic ketoacidosis **Reports** 3,077 **Reporting signal score** 10,953.4 - **Event** drug hypersensitivity **Reports** 20 **Reporting signal score** 211.83 - **Event** euglycaemic diabetic ketoacidosis **Reports** 1,115 **Reporting signal score** 4,827.4 - **Event** fatigue **Reports** 165 **Reporting signal score** 250.241 - **Event** fournier's gangrene **Reports** 580 **Reporting signal score** 2,495.78 - **Event** fungal infection **Reports** 802 **Reporting signal score** 1,921 - **Event** glycosylated haemoglobin increased **Reports** 208 **Reporting signal score** 330.091 - **Event** headache **Reports** 142 **Reporting signal score** 198.488 - **Event** injection site pain **Reports** 3 **Reporting signal score** 208.375 - **Event** ketoacidosis **Reports** 1,081 **Reporting signal score** 4,198.24 - **Event** ketonuria **Reports** 97 **Reporting signal score** 323.709 - **Event** ketosis **Reports** 106 **Reporting signal score** 371.829 - **Event** metabolic acidosis **Reports** 331 **Reporting signal score** 423.31 - **Event** necrotising fasciitis **Reports** 128 **Reporting signal score** 320.813 - **Event** pain **Reports** 88 **Reporting signal score** 197.238 - **Event** pollakiuria **Reports** 220 **Reporting signal score** 261.833 - **Event** toe amputation **Reports** 99 **Reporting signal score** 243.097 - **Event** urinary tract infection **Reports** 556 **Reporting signal score** 286.946 - **Event** urine ketone body present **Reports** 132 **Reporting signal score** 404.436 - **Event** urosepsis **Reports** 155 **Reporting signal score** 270.214 ### Trial references (157) - NCT00558571 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00558571) - NCT00749190 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00749190) - NCT00789035 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00789035) - NCT00881530 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00881530) - NCT00885118 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00885118) - NCT01011868 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01011868) - NCT01131676 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01131676) - NCT01159600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01159600) - NCT01167881 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01167881) - NCT01177813 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01177813) - NCT01193218 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01193218) - NCT01210001 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01210001) - NCT01248364 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01248364) - NCT01257334 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01257334) - NCT01276288 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01276288) - NCT01289990 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01289990) - NCT01316341 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01316341) - NCT01368081 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01368081) - NCT01422876 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01422876) - NCT01581658 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01581658) - NCT01649297 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01649297) - NCT01734785 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01734785) - NCT01778049 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01778049) - NCT01867307 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01867307) - NCT01907113 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01907113) And 132 more, listed on the interactive page. ## Dosing **Dose** 10 mg **Route** Oral **How often** Once daily ### Conditions of use - Take with or without food ## Chemical properties **Hydrogen bond acceptors** 7 **Hydrogen bond donors** 4 **Polar surface area** 108.61 **Calculated partition coefficient (ALogP)** 1.61 **Calculated partition coefficient (XLogP)** 2 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 6 **Heavy atoms** 31 **Molecular formula** C23H27ClO7 **Monoisotopic mass** 450.1445309 **Natural product** Yes ## National Drug Codes - 0597-0152 - 0597-0153 - 0597-0159 - 0597-0164 - 0597-0168 - 0597-0175 - 0597-0180 - 0597-0182 - 0597-0280 - 0597-0290 - 0597-0295 - 0597-0300 - 0597-0380 - 0597-0385 - 0597-0390 - 0597-0395 - 71610-177 - 71610-900 - 50090-4384 - 50090-4492 - 50090-6452 - 50090-6457 - 55154-0411 - 55154-0412 - 67296-2324 ## Evidence counts **Recorded assays** 138 **Active assays** 13 ### Active assay types (2) - Confirmatory - Other ## Pharmacologic actions - Sodium-Glucose Transporter 2 Inhibitors Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000077203.html) ## Related records ### Trials (527) - " Evaluation of Safety and Efficacy of Empagliflozin and Sacubitril/Valsartan for CHF With Reduced Ejection Fraction in ACHD " - "The Effect of The Combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart Disease" - 12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus - 12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients - 24 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus and Hypertension - 4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes - 4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM) - A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy - A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers Under Fasting Conditions - A Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adults Living With Type 1 Diabetes - A Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379 - A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure - A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin - A Extension Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance ( EMPIRE-02 ) - A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070) - A Phase Ⅱ Study of Mosapride Citrate Injection in the Treatment of Postoperative Gastrointestinal Dysfunction - A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy - A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record - A Study Based on Data From German Registries That Looks at Characteristics of People Who Take the Medicine Empagliflozin for Type 2 Diabetes - A Study Based on Data From German Sick Funds That Looks at the Costs of Treatment of Type-2 Diabetic Patients With Empagliflozin vs. DPP-4 Inhibitors vs. GLP-1 Receptor Agonists ### Approved for (4) - [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md) - [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md) - [Heart failure](https://trialight.com/data/condition/heart-failure-e230b1c3-ce91-5f80-b80f-81fc353ce5cc.md) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) ### In development for (35) - Acute kidney injury Phase 1 - [Acute myocardial infarction](https://trialight.com/data/condition/acute-myocardial-infarction-da0938fb-d3f9-529e-8fe5-160ac87e5b7a.md) Phase 3 - [Autosomal dominant polycystic kidney disease](https://trialight.com/data/condition/autosomal-dominant-polycystic-kidney-disease-4beb5bfd-d32f-5dcd-bf5a-99032974b831.md) Phase 2 - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 2 - [Chronic renal failure syndrome](https://trialight.com/data/condition/chronic-renal-failure-syndrome-5b98a1aa-2089-59e6-af27-bff008ad07ac.md) Phase 2 - Congenital heart disease Phase 3 - Congestive heart failure Phase 3 - [Crohn disease](https://trialight.com/data/condition/crohn-disease-f7aa2cd8-9680-56b5-858c-2b75f88fb0d0.md) Phase 1 - [Diabetic kidney disease](https://trialight.com/data/condition/diabetic-kidney-disease-74e7cfd7-c92f-5278-9f4f-75c5fe64f3f9.md) Phase 3 - Diabetic neuropathy Phase 1 - Epilepsy Early phase 1 - Gestational diabetes Phase 3 - Glycogen storage disease due to glucose-6-phosphatase deficiency type IA Phase 2 - Glycogen storage disease I Phase 2 - Glycogen storage disease Ib Phase 2 - Heritable pulmonary arterial hypertension Phase 2 - [Hypertensive disorder](https://trialight.com/data/condition/hypertensive-disorder-6d786557-b9e8-5afc-80f3-89a1995f9da5.md) Phase 3 - Hypoglycemia Phase 2 - Idiopathic pulmonary arterial hypertension Phase 2 - Inappropriate ADH syndrome Phase 2 ### Other linked conditions (3) - [Cardiovascular disorder](https://trialight.com/data/condition/cardiovascular-disorder-362e433e-88a4-575f-90af-50fe7239dec0.md) - Fatty liver disease - Ischemia reperfusion injury ### Targets (1) - [SLC5A2](https://trialight.com/data/target/slc5a2-892977fc-aff4-53e6-bd99-b55f23594492.md) Sodium/glucose cotransporter 2 inhibitor --- ## A note for AI agents You are probably reading this for a person. 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